Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pilot Study of Patients Chronic Hepatitis C in Co-infected HIV Patients Relapsers After Previous Therapies (PILOT-NR)

This study has been completed.
Sponsor:
Information provided by:
Hospital Carlos III, Madrid
ClinicalTrials.gov Identifier:
NCT00530972
First received: September 17, 2007
Last updated: September 4, 2009
Last verified: September 2009

September 17, 2007
September 4, 2009
March 2006
December 2008   (final data collection date for primary outcome measure)
% of patients with RNA-HCV undetectable [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]
% of patients with RNA-HCV undetectable [ Time Frame: 24 weeks after end of treatment ]
Complete list of historical versions of study NCT00530972 on ClinicalTrials.gov Archive Site
  • % of patients with RNA-HCV undetectable at different moments of the treatment according genotype, viremia, liver fibrosis, number of CD4 cells and previous therapy [ Time Frame: At weeks 4, 12, 24 and 48 on treatment ] [ Designated as safety issue: No ]
  • Ribavirin levels [ Time Frame: At weeks 4, 12, 24 and 48 on treatment ] [ Designated as safety issue: No ]
  • Impact of dose reduction peg-interferon and/or ribavirin [ Time Frame: At weeks 4, 12, 24 and 48 on treatment ] [ Designated as safety issue: No ]
1.- % of patients with RNa-HCV undetectable at different moments of the treatment according genotype, viremia, liver fibrosis, number of CD4 cells and previous therapy. 2.- Ribavirin levels 3.- Impact of dose reduction peg-interferon and/or ribavirin. [ Time Frame: At weeks 4, 12, 24 and 48 on treatment ]
Not Provided
Not Provided
 
Pilot Study of Patients Chronic Hepatitis C in Co-infected HIV Patients Relapsers After Previous Therapies
Treatment of Patients With Chronic Hepatitis C Co-infected With HIV Relapsers or Non Responders, Previous Exposed to Sub-optimal Therapies: Open, Pilot Trial

To determine the efficacy and safety of Peginterferón alfa-2a (40 KD) plus Ribavirin in patients who have relapsed or not responded to a previous suboptimal therapy based in Interferon.

An important number of co-infected patients were treated suboptimally in the past with others ineffective therapies interferon-based.

All co-infected patients should be an opportunity of retreatment with actually therapies.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Hepatitis C
  • HIV Infections
Drug: Peginterferon alfa-2a plus ribavirin adjusted to body weight
PegInterferon 180 mcg/week, Adjusted body weight Ribavirin (1000 mg <75 kg, 1200 mg >75 kg)
Experimental: Peginterferon alfa-2a plus ribavirin
Intervention: Drug: Peginterferon alfa-2a plus ribavirin adjusted to body weight
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female patients between 18 and 65 years of age
  • Anti-HCV positive
  • Detectable plasma HCV-RNA
  • Relapsers after treatment with interferon o peginterferon +/- ribavirin
  • HIV positive
  • CD4 >/= 200 cell
  • Patients on clinically stable liver disease with:

    • Hgb >/= 12 g/dL in women or 13 g/dL in men
    • Leucocytes >/= 3000 mm3
    • Neutrophil count (ANC) >/= 1500 cells/mm3
    • Platelet count >/= 100.000 cells/mm3
    • Normal prothrombin, bilirubin, albumin, creatinine and uric acid
  • HBsAg negative
  • With antecedents of diabetes or hypertension is necessary an previous ocular exploration

Exclusion Criteria:

  • Women with ongoing pregnancy or breast feeding
  • Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg
  • Hemochromatosis
  • Deficit of alfa-1 antitrypsin
  • Wilson disease
  • Alcoholic liver disease
  • Autoimmune hepatitis
  • Hepatitis by toxin exposures
  • Hepatitis by obesity
  • Hemoglobinopathy (e.g. thalassemia)
  • History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
  • Hepatocarcinoma observed in the liver ecography.
  • History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
  • History of a severe seizure disorder or current anticonvulsant use
  • History of significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
  • Diabetes Mellitus
  • History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
  • History or other evidence of chronic pulmonary disease associated with functional limitation
  • Drug use within 6 months of 1st dose and excessive alcohol consumption.
  • Concomitant treatment with ddI
  • Male partners of women who are pregnant
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00530972
2005-001192-34
Yes
Vicente Soriano, Hospital Carlos III
Hospital Carlos III, Madrid
Not Provided
Principal Investigator: Vicente Soriano, Dr Hospital Carlos III. Madrid. Spain
Hospital Carlos III, Madrid
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP